Food and Drug Administration Amendments Act of 2007

Food and Drug Administration Amendments Act of 2007
Great Seal of the United States
Long titleTo amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.
Enacted bythe 110th United States Congress
EffectiveSeptember 27, 2007
Citations
Public law110-85
Statutes at Large121 Stat. 823
Codification
Acts amendedFederal Food, Drug and Cosmetic Act
Titles amended21 U.S.C.: Food and Drugs
U.S.C. sections amended301
Agencies affectedFood and Drug Administration
Legislative history
  • Introduced in the House of Representatives as H.R. 3580 by John Dingell (D–MI) on September 19, 2007
  • Committee consideration by United States House Committee on Energy and Commerce
  • Passed the House on September 19, 2007 (405-7)
  • Passed the Senate on September 20, 2007 (Unanimous Consent) with amendment
  • House agreed to Senate amendment on September 20, 2007 (cleared) with further amendment
  • Senate agreed to House amendment on September 20, 2007 (cleared)
  • Signed into law by President George W. Bush on September 27, 2007

President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices.[1] It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.[2]

The FDAAA extended the authority to levy fees to companies applying for approval of drugs, expanded clinical trial guidelines for pediatric drugs, and created the priority review voucher program, amongst other items.

  1. ^ "Law Strengthens FDA". Food and Drug Administration.
  2. ^ John, Dingell (27 September 2007). "Cosponsors - H.R.3580 - 110th Congress (2007-2008): Food and Drug Administration Amendments Act of 2007". www.congress.gov.